Safety and Efficacy Evaluation of Cosmetics

China is a big country in the production and consumption of skin care products. With the continuous development of the economy, the consumption level of Chinese residents is also increasing. The market size of skin care products has expanded significantly. Cosmetics have also changed from luxury goods to indispensable daily necessities, and industry competition has become increasingly fierce. fierce. At a time when new brands, new effects, and new ingredients are constantly emerging, consumers pay special attention to the safety of product ingredients and the authenticity of efficacy. In order to strengthen the management of the safety and efficacy of cosmetics, the State Food and Drug Administration requires cosmetics manufacturers to evaluate the efficacy claims and safety of cosmetics before the products are put on the market.

On January 3, 2020, the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations") were reviewed and approved by the 77th executive meeting of the State Council. On June 16, Premier Li Keqiang signed a State Council decree, promulgating the "Regulations", which will come into force on January 1, 2021. According to the latest "Cosmetics Supervision and Administration Regulations", the efficacy claims of cosmetics should have sufficient scientific basis. Cosmetics registrants and filers shall publish the abstracts of the literature, research data or product efficacy evaluation data on which efficacy claims are based on the special website specified by the drug regulatory department of the State Council, and accept social supervision.

A series of policies such as various management measures, work norms, and technical guidelines to be implemented in 2021. Will there be any unclear test items during the product filing process? Not sure about the filing process? Frequent filing audit problems?

NOA has built a first-class testing platform around cosmetics, providing customers with product filing testing, formula design draft regulations review, product safety evaluation, efficacy evaluation project testing, system operation guidance, legal knowledge answers, etc. Customer assistance. Our one-stop solution can assist companies to produce satisfactory, safe and effective cosmetics, and provide customers with professional analysis, testing, testing, research and development, regulatory consultation and other technical services at any stage of product development and production.

Cosmetics Efficacy Claims Evaluation Project Requirements

NO.	Efficacy Claims	Human Efficacy evaluation Test	Consumer Performance Test	Laboratory Test	Literature Data or Research Data
1	Freckle-removing and whitening①	√
2	Sunscreen	√
3	Anti-hair loss	√
4	Acne-removing	√
5	Nourishing②	√
6	Repairing②	√
7	Anti-wrinkle	*	*	*	△
8	Tightening / Firming	*	*	*	△
9	Relieving / Soothing	*	*	*	△
10	Oil-control	*	*	*	△
11	Exfoliating	*	*	*	△
12	Hair breakage prevention	*	*	*	△
13	Anti-dandruff	*	*	*	△
14	Moisturizing	*	*	*	*
15	Hair-care	*	*	*	*
16	Specific claims (claims to be suitable for sensitive skins, be a tear-free formula)	*	*
17	Specific claims (ingredient efficacy)	*	*	*	*
18	Claims to be gentle (no stimulation)	*	*	*	△
19	Claims of quantitative indicators (time, statistical data, etc.)	*	*	*	△
20	New efficacy	Select the appropriate evaluation basis according to the specific efficacy claims.

Note：

1. Items drawn in the option bar are required;

2. Drawing * in the Options Bar is optional, but you must select at least one of it;

3. The △ is painted in the option bar, but it must be used together with the human efficacy evaluation test, consumer use test, or laboratory test.

Note：

① Only plays the effect of freckle whitening through physical covering, and clearly has a physical effect in the label, can be exempted from submitting the application of product efficacy claim evaluation materials;

② If the effect of action is only hair, can choose real hair in vitro for evaluation.

Surveillance Project

Cosmetic Safety Testing	Cosmetics efficacy test	Consumer testing	Toothpaste efficacy test	laboratory test	In vitro substitution experiments
Skin closed patch test (24h)	whitening	crease resistant	White teeth	Dry combing (hair care)	In vitro chromosomal aberration assay in mammalian cells
Skin Closed Spot Stick Test (CMA)	Prevent take off	Compact	Reduce plaque	Wet combing (hair care)	In vitro gene mutation in mammalian cell assay
Skin closed patch test (48h)	remove acne	leisurely	Fresh breath	Gloss (hair care)	Ames test
Sensitive skin patch（24h）	servicing	oil-control	Maintain teeth and periodontal tissue (including gingival) health	Friction force (repair)	Cytotoxicity test
Light spot paste	crease resistant	Exfoliator	Keep your mouth healthy	Single hair stretch / toughness (hair resistant)	Cosmetic skin irritation test
Safety evaluation of human trial experiment	Compact	Prevent broken hair	Reduce tooth stains	Leave incense (fragrance)	Keratocyte assay of acute toxicity in cosmetics
Sensitive skin trial (questionnaire survey and screening)	leisurely	anti-dangdruff	Reduce soft scale	Anti-wrinkle effect
Sensitive skin trial (questionnaire survey + lactic acid tingling test screening)	oil-control	Moisture	Inhibition of dental plaque	Compact effect
Sensitive skin trial (questionnaire survey + lactic acid tingling test + TEWL screening)	Exfoliator	Hair care	Anti-dentin sensitive	leisurely
Human skin open skin patch test	anti-dangdruff	Specific claims (declared sensitive skin, tear-free formula)	Remove stains and add white	anti-dangdruff
Evaluation of Human Repetitive Injury Spot Tie Test (HRIPT)	Moisture	Specific claims (raw material efficacy)	Anti-dental stones	Antioxidant
Evaluation of Human Repetitive Injury Spot Tie Test (HRIPT)	Makeup waterproof performance test	Say mild (no stimulating)	Reduce gingival inflammation
Acogenicity (Trial test)	Makeup durability test	Proclaim to quantitative indicators(Time, statistics, etc.)
Aclinicity (Trial test)	cleaning
Tearless Formula (Trial Test)	take off formal dress and ornaments
	Beauty modification
	lose hair or feathers
	deodorization

Service Process

Q&A

What content should be filled in for the summary of cosmetics efficacy claims?

According to article 19 of the "Cosmetics efficacy Declaration Evaluation Code": the summary of the cosmetics efficacy declaration basis should briefly list the content of the product efficacy declaration basis, including at least the following information:

(1) Basic product information;

(2) Efficacy claims evaluation projects and evaluation institutions;

(3) A brief description of the evaluation methods and results;

(4) The conclusion of the efficacy claim evaluation shall clarify the relationship between the efficacy claim of the product and the evaluation method and results.

How can cosmetics that can be directly recognized by the senses or physically only by means operate on the filing system to avoid publishing the summary of the basis for product efficacy claims?

According to Article 4 of the "Evaluation Specifications for Cosmetics Efficacy Claims": Cosmetics registrants and filers shall, in accordance with the requirements of this specification, upload the basis for product efficacy claims on the special website designated by the State Drug Administration when applying for registration or filing. Summary.

Products exempted from publishing the summary of the basis for product efficacy claims need to fill in the product efficacy claims in the "Efficacy Claims" module of the general cosmetic filing management system. Check "Yes" in the "Whether or not" column, and the "Remarks" column will automatically display "According to the "Evaluation Specifications for Cosmetics Efficacy Claims", those who can be directly identified through the senses such as vision and smell can be exempted from publishing the basis of product efficacy claims. Abstract” description, and then submit an efficacy claim.

What are the precautions for adding chemical sunscreen to ordinary cosmetics?

The chemical sunscreen used in non-sunscreen products should be tested for chemical sunscreen; chemical sunscreen content of 0.5% (w / w) (except riners, perfumes, nail polish), in addition to the specified items, skin phototoxicity test, skin allergy test and SPF value; chemical sunscreen can be "stabilizer" or "product protector" according to the product reality, not as "skin conditioner".

How to correctly understand the cosmetic efficacy claim evaluation? How to deal with the registered and registered products to meet the requirements of cosmetics efficacy declaration management regulations?

In order to implement the "Regulations on the Supervision and Administration of Cosmetics" and standardize and guide the evaluation of cosmetic efficacy claims, the State Food and Drug Administration has formulated and issued the "Specifications for the Evaluation of Cosmetics Efficacy Claims" (No. 50 of 2021, hereinafter referred to as the "Specifications"). According to the requirements of the "Specification", not all cosmetics need to be evaluated for efficacy claims. For most of the listed cosmetics that can be directly identified by sight, smell and other senses (such as cleaning, makeup removal, beauty modification, aroma, body refreshment, hair coloring, perm, hair color care, hair removal, deodorization and auxiliary shaving or shaving or shaving) Claims that the effect occurs through simple physical covering, adhesion, friction, etc.) are exempted from efficacy evaluation; only a few have strong functions and are strictly managed according to drugs or quasi-drugs in most countries and regions (such as freckle removal). Whitening, sunscreen, anti-hair loss, acne removal, nourishment, repair, etc.) claims, the human body efficacy evaluation test is only required; other efficacy claims can be conducted through literature research, research data analysis, or cosmetic efficacy claim evaluation tests as appropriate. Evaluation.

For cosmetics that have been registered and filed before May 1, 2021, cosmetic registrants and filers should upload a summary of the basis for the efficacy claims of the relevant products in accordance with the transition period policy. After the registrant or filer evaluates the efficacy claims of related products in accordance with the requirements of the "Specifications", if the evaluation results cannot support the content of the efficacy claims involved in the product name or label, they may file a change application before the expiry of the transition period. The classification code of the product is adjusted, and the relevant content of the product name or label is modified to make it meet the regulatory requirements.

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NOA inspection services currently cover Europe, Australia, Russia, some Middle East regions and most regions in China. NOA can ensure the consistency and continuity of customer service in different regions, and eliminate the impact of unfamiliar environments on customer quality. The guarantees and the impact of project implementation enable customers to participate in different markets across the country or around the world with flawless quality.

Safety and Efficacy Evaluation of CosmeticsProfessional services for regulations and technic, accelerate new products to market.

Safety and Efficacy Evaluation of Cosmetics

Safety and Efficacy Evaluation of Cosmetics
Professional services for regulations and technic, accelerate new products to market.